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Previously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory pain MIAMI, FL / ACCESS Newswire / March 23, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data demonstrating that Mira-55 did not produce cannabinoid-like central nervous system (CNS) side effects across a comprehensive battery of validated behavioral assays. The observed profile was differentiated from both Δ9-tetrahydrocannabinol (THC), the primary psychoactive component of cannabis, and the CB1 receptor antagonist rimonabant.

Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings MIAMI, FLORIDA / ACCESS Newswire / March 4, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator. The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.

Company to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research (AACR)Annual Meeting MIAMI, FLORIDA / ACCESS Newswire / February 3, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist. To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 last subjects remaining.

Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the initiation of the multiple ascending dose (MAD) portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company also announced that it has selected chemotherapy-induced peripheral neuropathy (CIPN) - a common and debilitating side effect of cancer treatment - as the lead indication for its planned Phase 2a clinical evaluation.

Manuscript accepted for publication in Frontiers in Pharmacology, "Oral Administration of Ketamir-2, a Novel Ketamine Analog, Attenuates Neuropathic Pain in Rodent Models via Selective NMDA Antagonism" details Ketamir-2's superior performance in two validated neuropathic pain models and supports advancement to Phase 2a clinical trials by year-end 2025. MIAMI, FL / ACCESS Newswire / August 12, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the acceptance of a second peer-reviewed manuscript describing its lead oral drug candidate, Ketamir-2, in Frontiers in Pharmacology.

Topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases MIAMI, FLORIDA / ACCESS Newswire / July 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data showing that its topical Ketamir-2 cream delivered similar and consistent pain relief compared with injected morphine in a validated animal model of acute and inflammatory pain. In the study, Ketamir-2 cream was applied topically to the affected area 30 minutes before pain was induced using the formalin model, a widely accepted preclinical method for evaluating both acute and inflammatory pain.

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion as the Company prepares to launch U.S. Phase 2a by year-end MIAMI, FLORIDA / ACCESS Newswire / July 29, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Ketamir-2, a novel oral NMDA receptor antagonist for the treatment of neuropathic pain. The IND submission included a comprehensive data package encompassing preclinical pharmacology, safety, and toxicology studies, including a pivotal neurotoxicity study in Sprague-Dawley rats which showed no evidence of brain lesions or adverse CNS effects-a key distinction from traditional ketamine, which has been associated with NMDA-linked neurotoxicity and the formation of Olney lesions in similar preclinical models.